Website InnoCare Pharma Inc. (US)
Job Description:
Responsible for the quality management of clinical development
Job Responsibilities:
• Responsible for the development and update of clinical QA SOP
• Responsible for clinical QMS evaluation and maintenance
• Responsible for clinical audits, including investigator sites, vendors, and in-house audits
• Review IND submissions and other R&D submission documentation
• Summarize and analyze audit findings, organize trainings and communications if
necessary
• Cooperate with all clinical functions to prepare, organize, and follow up clinical
inspections
• Support compliance activities for site Quality Operations in accordance to InnoCare
Pharma Inc.’s standards, procedures and GCP.
• Collaborate with site personnel to provide guidance and determine resolution for
manufacturing issues
• Ensure accurate and timely maintenance and review of manufacturing investigations,
CAPAs, change controls and complaints
• Review and approve manufacturing procedures
• Support regulatory inspections and audits by ensuring inspection readiness within
facility
• Perform analysis on quality indicating data and identifying trends
• Provide oversight for trending of quality compliance metrics
• Work in a collaborative team setting with quality counterparts
• Other responsibilities, as necessary.
Qualifications and requirements:
• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
• Minimum of 5 years’ experience of clinical development and 3 years’ experience of
clinical QA
• Knowledge of Proficient in FDA, ICH-GCP/China GCP and clinical trial related regulations
and guidelines
• Inspection experience is preferred
• Great attention to detail and ability to follow procedures
• Candidate must be highly organized and capable of working in a team environment with
a positive attitude, under minimal supervision
• Good written and verbal communication skills are required
• Ability to summarize and present results; experience with a team-based collaboration is
a must
• Must be able to interpret problems and effectively determine appropriate resolutions
that ensure compliance and minimize risks
• Must exhibit strong leadership skills and effectively develop others
• Ability to collaborate well with stakeholders, customers and peers
• Must exhibit strong decision-making ability and think creatively while maintaining
compliance and quality
• Must be able to discern the criticality of issues and communicate to management
regarding complex issues
• Ability to manage conflict and issues that arise with internal team and external
customers/partners
• Fluent English and Mandarin
• Flexibility with work hours; night TC with corporate office in China
• Frequent travels
Reports to: Chief Medical Officer/Head of Quality Assurance
Contact: E-mail CV to: Alice.Schies@innocarepharma.com. Mention that you see this JD on the SAPA website.